Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021880

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NDA 021880 describes REVLIMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 021880
Tradename:REVLIMID
Applicant:Celgene
Ingredient:lenalidomide
Patents:21
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021880
Generic Entry Date for 021880*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021880
Suppliers and Packaging for NDA: 021880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-00 100 CAPSULE in 1 BOTTLE (59572-402-00)
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 59572-402-28 28 CAPSULE in 1 BOTTLE (59572-402-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Dec 27, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2022
Regulatory Exclusivity Use:FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE TREATMENT)
Regulatory Exclusivity Expiration:May 28, 2026
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
Regulatory Exclusivity Expiration:May 28, 2026
Regulatory Exclusivity Use:INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)

Expired US Patents for NDA 021880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006   Try a Free Trial   Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013   Try a Free Trial   Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005   Try a Free Trial   Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School
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